Apotex Recalls Dorzolamide HCI/Timolol Maleate Ophthalmic Solution Due to Particulates
Apotex Inc. is recalling specific lots of Dorzolamide HCI/Timolol Maleate Ophthalmic Solution because they may contain small particulates.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a risk of temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, aligning with the Moderate severity criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Apotex Inc. is recalling 119,794 bottles of Dorzolamide HCI/Timolol Maleate Ophthalmic Solution, 10mL bottles, manufactured in Toronto, Ontario, Canada. The recall covers lots JN1060, JN1061, and JN1062 with an expiration date of 06/12. The product was distributed nationwide and in Puerto Rico.
The recall was initiated because the identified lots may contain small particulates. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions. The product is a prescription-only sterile ophthalmic solution intended for topical application in the eye.
The recalled product
- Product
- Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
- Manufacturer
- Apotex Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 119,794
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: JN1060
- JN1061
- JN1062
- Exp 06/12
Distribution
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